FDA First: Four New Tobacco Products Rejected for Sale

Thanks to previously unused authority granted by a recent law, the FDA has rejected the sale of four new tobacco products, a first for the Administration according to a New York Times article published online last week.

FDA officials announced last week that, although they authorized the sale of two new products made by the Lorillard Tobacco Company—known most famously for its Newport brand of cigarettes— the Agency rejected the proposed sale and marketing of four others.

“This is the first time in history,” Matthew L. Myers, president of the advocacy group Campaign for Tobacco-Free Kids, told the New York Times, “that a federal agency has told tobacco companies that they could not market a new or modified cigarette because of the public health problems they pose.”

Due to the terms of the Family Smoking Prevention and Tobacco Control Act (the Act) passed under President Obama in 2009, FDA officials could not publicly name the products they rejected nor the specific reasons why. The law, which aims to discourage minors and young adults from smoking, gives the FDA the power to reject cigarettes and other tobacco products its scientists believe pose public health risks far greater than comparable products already for sale.

Before 2009, cigarettes were made without any federal regulation as to what ingredients could be included in the tobacco. In terms of marketing, it was left up to the states to determine where and how tobacco products could be sold. The FDA now not only controls which cigarette products can be released for sale, but also must approve any new loose rolling tobacco, snuff and chewing tobacco products before they become available to consumers.

While many share the sentiment that the FDA’s use of its new power is historic, it is unclear how the Administration will proceed in encounters with big tobacco corporations. According to commissioner Dr. Margaret A. Hamburg, the FDA is the only agency in the world that possesses such power.  After the precedent-setting rejection of these four products, federal officials, according to The Times, will now study how best to exercise the FDA’s newfound regulatory muscle in the future.

The battle for tobacco regulation hasn’t been entirely one-sided, however, as the industry has notched some small victories against federal regulators. Among the provisions granted by the Act, the FDA attempted to require companies to print graphic images on their warning labels. To date, the tobacco industry, thanks in part to some formidable legal firepower, officials have commented, has successfully challenged this arm of the FDA’s authority in court.